Dermocosmetic Bioactive: Safety Assessment and Regulatory Challenges.

Objective: This review investigates the regulatory framework for dermocosmetic bioactive in functional skincare, focusing on products with both cosmetic and pharmaceutical characteristics. The global regulatory environment, with comparisons between the EU, the US, and India, will be analyzed, emphasizing the duality in regulation. Safety assessments, bioavailability, and toxicity concerns will be key focus areas, especially considering the impact of emerging technologies such as nanotechnology and AI-driven formulation development.

Method: A comprehensive literature search was performed using PubMed and Google Scholar electronic databases. This involves a comparative analysis of regulatory frameworks governing dermocosmetic bioactives across the EU, US, and India, focusing on understanding differences and similarities in their approaches. Additionally, the review will cover safety assessment techniques, including in vitro methods, ex vivo skin permeation models, and bioavailability studies to evaluate product safety and efficacy. The exploration extends to emerging technologies such as nanotechnology and the use of machine learning for predictive toxicology. It also addresses virtual clinical trials and the integration of "-omics" data into safety evaluations, offering new insights into regulatory compliance and risk assessment.

Result: The review highlights the need for adaptive regulations to balance innovation with consumer safety. Regulatory differences in the EU, US, and India reflect varying approaches to dual- function products.

Conclusion: Advances in nanotechnology, AI, and machine learning offer new pathways for formulation development and safety assessments, suggesting a future where regulatory frameworks evolve to accommodate these innovations while ensuring product safety and efficacy.